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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER
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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER Back to Search Results
Model Number CV-180
Device Problem Electrical Power Problem (2925)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user report was confirmed.A faulty cp board was corroded and causing no image to appear.The patient board set was also corroded.Both of these components will require replacing.If additional information becomes available following the device evaluation, a supplemental report will be filed.
 
Event Description
The customer reported that near the end of the procedure, they discovered that saline had spilled inside of the evis exera ii video system center and caused electrical damage.According the initial reporter, the unit will turn on, but nothing will light up.Furthermore, the initial reporter confirmed that this occurred near the end of a diagnostic coloscopy and the procedure was completed using the subject device as the case was almost finished when the issue was noted.There was no patient harm reported.
 
Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user report was confirmed.A faulty cp board was corroded and causing no image to appear.The patient board set was also corroded.Both of these components will require replacing.If additional information becomes available following the device evaluation, a supplemental report will be filed.
 
Event Description
The customer reported that near the end of the procedure, they discovered that saline had spilled inside of the evis exera ii video system center and caused electrical damage.According the initial reporter, the unit will turn on, but nothing will light up.Furthermore, the initial reporter confirmed that this occurred near the end of a diagnostic coloscopy and the procedure was completed using the subject device as the case was almost finished when the issue was noted.There was no patient harm reported.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, the phenomenon likely resulted from faulty pc board.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
 
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Brand Name
EVIS EXERA II VIDEO SYSTEM CENTER
Type of Device
VIDEO SYSTEM CENTER
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key12884752
MDR Text Key285432598
Report Number8010047-2021-15201
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170215513
UDI-Public04953170215513
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCV-180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/04/2021
Initial Date FDA Received11/29/2021
Supplement Dates Manufacturer Received12/10/2021
Supplement Dates FDA Received12/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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